DIRECT HDL-CHOLESTROL LIQUID— 510(k) K982341

Name: FDA 510(k) clearance K982341
Creator: U.S. Food and Drug Administration
Published: 1998-07-30

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K982341 for DIRECT HDL-CHOLESTROL LIQUID, Substantially Equivalent on 1998-07-30. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1998-06-22
Decision date: 1998-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K982341

K-number listed on FDA's recall record

Z-1653-2016 — Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20160317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982341.

Data sourced from openFDA. This site is unofficial and independent of the FDA.